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Single Dose Escalation Study of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Glendale, California, 91206 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female (of non-child bearing potential) subjects ages ≥50 years of age.

- Diagnosis of probable AD (of mild to moderate severity), consistent with criteria from
both: NINCDS-Alzheimer's Disease and Related Disorders Association (ADRDA) and
DSM-IV-TR.

- MMSE score of 16-26 inclusive.

- Rosen-Modified Hachinski Ischemia Score ≤4.

- On a stable dose of background cholinesterase inhibitors or memantine for at least 60
days prior to dosing.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Diagnosis or history of other dementia or neurodegenerative disorders.

- Diagnosis or history of clinically significant cerebrovascular disease.

- Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro
hemorrhage, multiple white matter lacunes.

- History of allergic or anaphylactic reactions.

NCT00733642
Pfizer
Completed
Single Dose Escalation Study of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease

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Single Dose Escalation Study of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease
An Open Label, Single Dose Escalation Study Of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease
The purpose of this study is to determine whether single doses of PF-04360365 is safe and well tolerated in patients with Alzheimer's Disease.
Not Provided
Interventional
Phase 1
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Alzheimer's Disease
  • Biological: PF-04360365 1 mg/kg
    PF-04360365 1 mg/kg infused as a single dose
  • Biological: PF-04360365 3 mg/kg
    PF-04360365 3 mg/kg infused as a single dose
  • Biological: PF-04360365 5 mg/kg
    PF-04360365 5 mg/kg infused as a single dose
  • Biological: PF-04360365 10 mg/kg
    PF-04360365 10 mg/kg infused as a single dose
  • Experimental: PF-04360365 1 mg/kg
    Intervention: Biological: PF-04360365 1 mg/kg
  • Experimental: PF-04360365 3 mg/kg
    Intervention: Biological: PF-04360365 3 mg/kg
  • Experimental: PF-04360365 5 mg/kg
    Intervention: Biological: PF-04360365 5 mg/kg
  • Experimental: PF-04360365 10 mg/kg
    Intervention: Biological: PF-04360365 10 mg/kg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
July 2009
July 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female (of non-child bearing potential) subjects ages ?50 years of age.
  • Diagnosis of probable AD (of mild to moderate severity), consistent with criteria from both: NINCDS-Alzheimer's Disease and Related Disorders Association (ADRDA) and DSM-IV-TR.
  • MMSE score of 16-26 inclusive.
  • Rosen-Modified Hachinski Ischemia Score ?4.
  • On a stable dose of background cholinesterase inhibitors or memantine for at least 60 days prior to dosing.

Exclusion Criteria:

  • Diagnosis or history of other dementia or neurodegenerative disorders.
  • Diagnosis or history of clinically significant cerebrovascular disease.
  • Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro hemorrhage, multiple white matter lacunes.
  • History of allergic or anaphylactic reactions.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00733642
A9951008
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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